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A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum Disorder

This study is currently recruiting participants.
Verified October 2017 by Jian-Jun Ou, Central South University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02879110
First Posted: August 25, 2016
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Davis family funding
University of California
University of Illinois at Chicago
Information provided by (Responsible Party):
Jian-Jun Ou, Central South University
  Purpose
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. Biological samples also will be collected, and stored to research related mechanisms.

Condition Intervention
Autism Spectrum Disorder Dietary Supplement: Sulforaphane Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-weeks, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Related Mechanism of Sulforaphane in Treatment of Autism Spectrum Disorder

Resource links provided by NLM:


Further study details as provided by Jian-Jun Ou, Central South University:

Primary Outcome Measures:
  • The change of social impairments of children with autism spectrum disorder [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Social impairments are measured by Social Responsiveness Scale


Secondary Outcome Measures:
  • The change of rigid interests and behaviors of children with autism spectrum disorder [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Rigid interests and behaviors are measured by Repetitive Behavior Scale - Revised

  • The change of clinical symptoms of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Clinical symptoms are measured by Aberrant Behavior Checklist

  • The change of other behavioral problems of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Other behavioral problems are measured by Achenbach's Child Behavior Checklist

  • The change of adaptive behaviors of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Adaptive behaviors are measured by Adaptive Behavior Assessment System, Second Edition

  • The change of clinical general impression of children with autism spectrum [ Time Frame: At baseline, 4 week, 8 week and 12 week/endpoint ]
    Clinical general impression is measured by Ohio State University Autism Clinical Global Impression

  • The change of heart rate as measured by stopwatch [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of weight as measured by weighing-machine [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of height as measured by Height measurement tools [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of blood routine test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of fasting blood-glucose as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of blood lipid as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of liver function as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of kidney function as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of thyroid function as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of HBV test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of helicobacter pylori test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of urine routine test as tested by clinical laboratory [ Time Frame: At baseline and 12 week/endpoint ]
  • Number of participants with treatment-related adverse events as assessed by Systematic Assessment for Treatment Emergent Effects [ Time Frame: At 4 week, 8 week and 12 week/endpoint ]

Other Outcome Measures:
  • The change of Oxidative stress indexes as tested by Oxidative stress indexes detection kit [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of Epigenetics indicators as tested by Epigenetics indicators [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of Cytokines & Chemokines as tested by Cytokines & Chemokines detection kit [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of Metabolites as tested by Metabolites detection kit [ Time Frame: At baseline and 12 week/endpoint ]
  • The change of RNA expression as tested by RNA expression detection kit [ Time Frame: At baseline and 12 week/endpoint ]

Estimated Enrollment: 120
Study Start Date: August 2016
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sulforaphane group
The patients will take sulforaphane for 12 weeks.
Dietary Supplement: Sulforaphane
Sulforaphane (SFN) is a compound within the isothiocyanate group of organosulfur compounds. It is obtained from cruciferous vegetables such as broccoli, Brussels sprouts or cabbages.
Other Name: 85313323
Placebo Comparator: Placebo group
The patients will take placebo for 12 weeks.
Other: Placebo
Placebo tablet is composed of starch.
Other Name: Starch tablet

Detailed Description:
In this proposed study, the investigators will evaluate the the efficacy, safety and related mechanism of sulforaphane in treatment of autism spectrum disorder (ASD). The study will recruit 120 ASD patients, then these patients will be randomized to sulforaphane group or placebo group (60 patients per arm) for 12 weeks clinic trial. Clinical efficacy and safety assessment will be done at screen/baseline, 4 week, 8 week and 12 week. The specific aims are to compare sulforaphane versus placebo on: 1) clinical core symptoms; 2) other behavioral problems and adaptive behaviors. The investigators hypothesize that (1) sulforaphane is superior to placebo in the treatment of clinical symptoms in patients with ASD, measured by the Social Responsiveness Scale, Aberrant Behavior Checklist, Repetitive Behavior Scale - Revised and Ohio State University Autism Clinical Global Impression; (2) sulforaphane is superior to placebo in the treatment of other behavioral problems and adaptive behaviors patients with ASD, measured by Achenbach's Child Behavior Checklist and Adaptive Behavior Assessment System, Second Edition; and (3) Biological samples will be collected, and stored so that the hypothesis sulforaphane may alter oxidative stress indexes or inflammatory biomarkers, and influence histone deacetylase inhibitor mechanism or inflammatory mechanism et al that may be significantly correlated with clinical improvement.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male with aged 10 to 15 years.
  2. Meet DSM-V diagnostic criteria for autism spectrum disorder, and been checked with Autism Diagnostic Interview-Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS).

Exclusion Criteria:

  1. With severe physical disease (i.e. congenital heart disease, thyroid disease, diseases with severe abnormality of liver or kidney function, diseases with abnormality vision or hearing et al.)
  2. With severe central nervous system disease (i.e. epilepsy et al).
  3. With other specific genetic syndromes (i.e. Fragile-X syndrome, Down's syndrome et al.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879110


Contacts
Contact: Jianjun Ou, M.D., Ph. D. 86-18684971485 oujianjun08@163.com
Contact: Jingping Zhao, M.D., Ph. D. 86-13808465728 zhaojingpingcsu@163.com

Locations
China, Guangdong
Guangzhou Huiai Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510000
Contact: Daomeng Cheng, M.D.       4336032@qq.com   
China, Hunan
The second Xiangya hospital of central south university Recruiting
Changsha, Hunan, China, 410001
Contact: Jianjun Ou, M.D., Ph.D    86-18694971485    oujianjun08@163.com   
Contact: Yanan Liu, Master    86-18008422158    610122024@qq.com   
Sub-Investigator: Yidong Shen, M.D., Ph.D         
Sub-Investigator: Yamin Li, M.D., Ph.D         
Sub-Investigator: Yanan Liu, Master         
Sub-Investigator: Lijuan Shi, Ph.D         
Sub-Investigator: Xilong Cui, Ph.D         
Sub-Investigator: Li Liu, Master         
Sub-Investigator: Yan Qiu, Master         
Sub-Investigator: Lu Xiao, Master         
Sponsors and Collaborators
Central South University
Davis family funding
University of California
University of Illinois at Chicago
Investigators
Study Chair: Jingping Zhao, M.D., Ph. D. Central South University
Study Director: Jianjun Ou, M.D., Ph. D. Central South University
Study Director: Hua Jin, M.D., Ph. D. Department of Psychiatry, University of California
Principal Investigator: Fengyu Zhang, Ph.D. Global Clinical and Translational Research Institute
Principal Investigator: Daomeng Cheng, M.D. Guangzhou Huiai Hospital
Principal Investigator: Renrong Wu, M.D.,Ph.D Central South University
Study Director: John M Davis, M.D.,Ph.D Department of Psychiatry, University of Illinoisat at Chicago
  More Information

Publications:

Responsible Party: Jian-Jun Ou, Assistant researcher, Central South University
ClinicalTrials.gov Identifier: NCT02879110     History of Changes
Other Study ID Numbers: ASD201512
First Submitted: August 15, 2016
First Posted: August 25, 2016
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jian-Jun Ou, Central South University:
Sulforaphane
clinic trial
Autism Spectrum Disorder
Efficacy
Safety
Mechanism

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Sulforafan
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents